Apparatus and method for suturing

ABSTRACT

The invention generally relates to devices and methods for suturing tissue. The invention provides methods and devices for suturing by pushing two ends of a suture through tissue from a proximal side of the tissue and fastening the two ends together on a distal side of the tissue through one operation of a trigger.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.61/577,038, filed on Dec. 18, 2011, and to U.S. Provisional ApplicationNo. 61/653,792 filed on May 31, 2012 the contents of each of which arehereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The invention generally relates to sutures, delivery devices, andmethods of use thereof.

BACKGROUND

Suturing is a common operation for closing surgical incisions. Suturingis also used to affix prostheses to target sites. However, suturing canpresent particular difficulties in laparoscopic and endoscopic surgerybecause those procedures take place entirety within a patient's body.

Some common devices deliver a suture to tissue within the body andfasten it by pushing one end of the suture through tissue and thenpulling the same end back through the tissue. This leaves two ends ofthe suture on the side closest to the physician, who then ties the twoends together. Other devices are designed to deliver a suture that isstructured to be cinched closed without tying a knot, but such suturesrequire time-consuming and difficult manipulation with endoscopicforceps or similar tools.

Since existing devices for laparoscopic suturing typically requiredifficult, time-consuming manipulation of the suture with forceps orother instruments, the incision must be kept open for a prolonged amountof time, which increases the risk of infection or other surgicalcomplications. Further, tying these sutures closed requires difficultmanipulation of small instruments, thus require a significant degree ofexpertise in operation

SUMMARY

The invention provides a mechanical self-locking suture and accompanyingdelivery device. The delivery device and suture of the invention areconfigured to deliver an open suture to a target tissue and then toautomatically close the suture upon deployment from the device. Thesuture is designed to become locked upon deployment from the deliverydevice into the target tissue. Delivery devices and sutures of theinvention allow for rapid delivery of sutures to target tissue, whileeliminating difficulties associated with manipulating small structureswithin the body during the suturing process. The delivery device andsuture of the invention are particularly useful for minimally-invasivesurgery (e.g. laparoscopic surgery) in which the ability of the surgeonvisualize the tissue and to manipulate the suture is limited.

In certain aspects, sutures of the invention include a flexible bodyhaving a first member disposed at one end and a second member disposedat the other. The two members define a fastening structure. For example,the first member can be a hook and the second member can be a loop.

Passage of the hook through the loop fastens the suture into a closedloop. The hook and the loop are generally disposed at the ends of thesuture body, such that the body can include a substantially smoothcross-sectional shape along its length (e.g., along about half or moreof the entire length of the suture). The suture is generally designed tobe pushed through tissue at either or both of its ends. Either or bothends can include, for example, a beveled tip or tapered portion tofacilitate insertion through tissue. In certain embodiments, the hook istapered from a proximal to a distal end.

Further, either or both end can include a structure designed toco-operate with a delivery device such as, for example, protrusions orindentations configured to mate with an insertion device. As the suturecan be designed to be pushed through tissue at both ends while having aU shape, the push-able surfaces can each face inward towards a center ofthe body member. In some embodiments, one or more of the protrusions orindentations are provided at distal ends of the suture. Insertion anddelivery can be accomplished through the use of insertion needlesprovided by a delivery device or manipulated by a practitioner.

In some embodiments, a suture of the invention requires no moving partsand can be integrally formed of a single piece of material, allowing foraffordable and easy manufacturing. Any suitable material can be usedsuch as, for example, a metal, a monofilament, a multifilament, abiodegradable material, a polymer, nylon, PDS, PGLA, PLA, anon-degradable material, polypropylene, polyethylene, or anickel-titanium alloy.

The end members of the suture act to fasten the suture. For example, inhook-and-loop embodiments, passage of the hook portion of the suturethrough the loop portion can fasten the suture closed in part becausethe loop can be dimensioned such that it is not substantially largerthan the hook member. The hook member can include barbs or wings (e.g.,fin-like structures) that do not freely pass through the opening of theloop. In some embodiments, either the fins or the loop must deformsomewhat for the hook to pass through the loop.

Pushing the hook through the loop fastens the suture in a secure, closedloop due to the action of the barb or fin structures on the hook and/ordue to the dimensions of the loop. Further, the loop can feature a“keyhole” shape having, for example, a portion of diminished width nearthe end such that tension on the suture causes the hook end of the bodyto be secured into the narrow end of the keyhole loop, thus locking thesuture in its closed conformation. In some embodiments, the secondmember includes an aperture with a wide section and a narrow section,the narrow section being distal to the wide section and having a widthsuch that the narrow section retains the first member. The second membercan further have a protrusion located distal to the aperture.

In other aspects, delivery devices of the invention include a shaft thathas a delivery mechanism at least partially disposed therein. Thedelivery mechanism is configured to releasably engage a suture at leastpartially disposed within the shaft in an open configuration, deliverthe suture from the shaft to a target tissue, form the suture into aclosed configuration beneath a surface of the target tissue, and releasefrom the closed suture.

In some embodiments, the device includes a trigger on a handle.Operation of the trigger causes a first end of a body member of thesuture to move towards a second end of the body, fastening the two endstogether. In certain embodiments, both ends of the suture are insertedinto tissue from a side of the tissue proximal to the operator and thesuture is closed and fastened on a side of the tissue distal from theoperator.

The shaft carries a suture (or a cartridge loaded with sutures) to atarget site in a tissue. Operation of the trigger fastens a suture inplace in a closed loop while releasing it from the delivery tip.

The delivery mechanism can operate via a needle member that pushes thesuture in a direction away from a handle of the device. The mechanismmay further include two (or more) push rods, each of which provides aneedle member at an end of the delivery mechanism distal to the handle.Each needle member couples with a portion of the suture for delivery.Delivery and fastening can be accomplished by the operation of one ormore of a delivery needle disposed within the shaft that pushes thesuture towards and into the tissue. For example, a needle member of thedelivery mechanism can push the suture away from the handle, towards thetarget. Fastening is accomplished through the action of the deliverymechanism. In some embodiments, delivery and fastening involves two pushrods in the delivery mechanism. The push rods can extend from the handleto the delivery tip. Each push rod terminates with an insertion needlethat couples with (e.g., holds and/or pushes) a portion of the suture.Operation of the trigger causes each push rod to translate relative tothe shaft and relative to the other push rod. Cooperative insertion anddelivery is accomplished via push rods that drive the ends of the suturethrough the tissue. Upon activation of the trigger, one push rod extendsfrom the delivery tip, following a curved path so that one end of thesuture meets the other end on a side of the tissue distal to thedelivery device. The push rods translate relative to each other and tothe shaft to coordinate the suturing. A predetermined sequence ofrelative translations of the two push rods can be coordinated by alinkage between each push rod and a slot wheel mechanism in the handleof the device having an irregular slot. The push rods extend along alength of the shaft from the handle to the delivery tip.

In certain embodiments, a single operation of the trigger causes a loopend of a suture to be pushed through the tissue while a hook end of thesuture is also pushed through the tissue from the same side (e.g., theproximal side, with reference to the operator holding the handle) andbrought into contact with the loop end on the distal side of the tissue.The hook member can be guided towards the loop member through the actionof a shape memory material in the insertion needles.

The independent and coordinated translation of the push rods andinsertion needles is governed by a linkage to a set of slot wheelsassociated with the handle. The trigger can include a squeezable handlethat interacts with gears to cause rotation of the slot wheel set. Thedevice can also include an articulation joint to bend the shaft.

In some embodiments, the delivery tip is configured to receive acartridge loaded with a plurality of sutures. Cartridges can be loadedwith sutures of different sizes, thus allowing the device to be used todeliver sutures of different sizes by swapping out cartridges. A singlecartridge form-factor may be loaded with sutures of varying sizes, e.g.,through the use of a spacer.

Another aspect of the invention provides a cartridge that holds suturesand can be loaded into a delivery device. The cartridges structurecooperates with the mechanical structure of the device so that thedevice can deliver and fasten sutures within a patient's body. Thecartridge is able to accommodate sutures of different sizes.

In some embodiments, the cartridge can use a spacer that is adapted toallow for delivery of different sizes of sutures using the sameapplicator device and the same sequence of needle movements. The spacercan be interchangeable within the cartridge, the cartridge can beinterchangeable within the device, or both. Within a cartridge, the sizeof the spacer is set according to the size of the sutures within thecartridge. A small spacer can be provided to accommodate long sutureswhile a large spacer accommodates short sutures.

In some embodiments, the cartridge has a release slot. The release slotis designed to exert some resistance, or friction, on the suture. Theresistance pulls a suture that is not fastened out of tissue duringretraction of the suture delivery device, to provide a fail-safemechanism for retrieving un-fastened sutures. Further, the resistancemaintains operable contact between the suture and the suture deliverydevice during delivery.

In certain embodiments, the cartridge can be inserted into an end of anshaft of the suture delivery device.

Other aspects of the invention provide a method for suturing tissue bydelivering to a wound at least one suture. At least one of the deliveredsutures includes a flexible body having two ends, a first memberdisposed at a first end of the body, and a second member disposed at asecond end of the body. Delivery according to the methods of theinvention causes the first end of the body to mate with and be retainedby the second end of the body, thereby forming the suture into a closedconfiguration.

Because the suture can be delivered by a device with an elongated shaft,the wound can be inside of a body (e.g., spaced away from the handle andoperator by a distance).

The first and second members generally define a fastening structure. Insome embodiments the first member is a hook (optionally tapered from aproximal to a distal end). The second member can present aloop-structure, e.g., an aperture. The aperture can further include awide section and a narrow section, the narrow section being distal tothe wide section and having a width such that the narrow section retainsthe first member.

Either or both of the first and second members may further include astructure such as a protrusion or indention to mate with a deliverydevice. Either protrusion may be located at an end of a suture (e.g., atdistal ends of the first or second member). The suture can include anysuitable material such as, for example, metal, a monofilament, amultifilament, a biodegradable material, a polymer, nylon, PDS, PGLA,PLA, a non-degradable material, polypropylene, polyethylene, and anickel-titanium alloy.

In certain aspects, the invention provides a method for suturing tissueby delivering to a wound at least one suture using a suturing devicethat includes an shaft configured to releasably carry the suture in anopen configuration and a delivery mechanism that forms the suture intothe closed configuration and releases it from the shaft.

Methods can include pushing the suture in a direction away from theoperator with a push rod or inserting at least a first end of the suturethrough an aperture in a second end of the suture. One or more needlemembers can be provided by one or more push rods. Where two push rodseach provide a needle member, the needle members can couple withportions of the suture.

In some embodiments, the method includes pushing two ends of the suturethrough tissue from a proximal side of the tissue and fastening the twoends together on a distal side of the tissue. This can be accomplishedthrough one single operation of a trigger. The suture is pushed intoplace at the surgical site by a mechanism of the delivery device coupledto the trigger. Methods further include delivering a suture at an angleaway from the shaft by articulating the shaft via an articulation joint.Suture sizes can be changed by changing a cartridge of sutures in thedevice.

Another aspect of the invention provides a method for securing a medicalprosthesis to tissue. Securing the prosthesis is accomplished throughdelivering a suture to a target tissue that has a prosthesis applied toit. The suture includes a flexible body having two ends, a first memberdisposed at a first end of the body, and a second member disposed at asecond end of the body. Delivery according to the methods of theinvention causes the first end of the body to mate with and be retainedby the second end of the body, thereby forming the suture into a closedconfiguration and securing the prosthesis to the tissue. The prosthesiscan be a mesh, such as a hernia mesh. Because the suture can bedelivered by a device with an elongated shaft, the target tissue can beinside of a body.

The prosthesis can be secured by employing a fastening structureprovided by the first and second members. In some embodiments the firstmember is a hook (optionally tapered from a proximal to a distal end).The second member can present a loop-structure, e.g., an aperture. Theaperture can further include a wide section and a narrow section, thenarrow section being distal to the wide section and having a width suchthat the narrow section retains the first member.

Suturing the prosthesis may be facilitated by a structure such as anindentation or protrusion on the first member, the second member, orboth. Such a structure can be provided to mate with a delivery device.Either protrusion may be located at an end of a suture (e.g., at distalends of the first or second member). The suture can include any suitablematerial such as, for example, a metal, a monofilament material, amultifilament material, a biodegradable material, a polymer, nylon, PDS,PGLA, PLA, a non-degradable material, polypropylene, polyethylene, and anickel-titanium alloy. In some embodiments, methods include suturing theprosthesis with an integrally formed suture.

Methods of the invention include securing the prosthesis with a sutureof a selected size. In some embodiments, this is by using aninterchangeable cartridge from a set in which the cartridges includesutures of differing sizes. The delivery tip of the shaft can beconfigured to house a suture cartridge that is pre-loaded with sutures.Suture cartridges can be pre-loaded with sutures of different sizes andthen interchangeably loaded into the delivery device. By these means, asingle suturing device can deliver sutures of different sizes. Eachsuture is delivered via a simple single trigger-pull procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate one embodiment of a suture applicator.

FIGS. 2A and 2B illustrate a suture applied by the suture applicator.

FIGS. 3A-3G illustrate various stages during application of a suture.

FIGS. 4A-4D illustrate fixating a hernia mesh to an abdominal wall.

FIGS. 5A-5B illustrate use of the suture applicator for wound closureapplications.

FIGS. 6A-6H illustrate application of a suture during wound closureoperation.

FIGS. 7A-7C show a suture according to certain embodiments.

FIGS. 8A and 8B illustrate operation of a delivery tip of a suturingdevice.

FIGS. 9A and 9B show an articulation joint.

FIG. 10 shows a suture cartridge.

FIGS. 11-13 show suture cartridges for use with different sized sutures.

FIG. 14 gives a view of components of a handle of a suturing device.

FIGS. 15A-15C depict a suture according to certain embodiments.

FIGS. 16 and 17 depict a applicator section.

FIGS. 18A-18F depict the operation of a suture applicator of certainembodiments.

FIG. 19 shows the structure of the clip feeder mechanism.

FIG. 20 illustrates the function of the clip feeder.

FIG. 21 shows the positioning of a suture in a clip feeder.

FIGS. 22A-22E show the advancement of a suture through the clip feeder.

FIGS. 23A-23E depict the operation of the comb driver mechanism of aclip feeder.

FIG. 24 shows a mechanism for connecting a cartridge.

DETAILED DESCRIPTION

The current invention provides sutures, delivery devices, and methodsfor fastening a suture to tissue. The invention provides methods anddevices for suturing by pushing two ends of a suture through tissue froma proximal side of the tissue and fastening the two ends together on adistal side of the tissue through one operation of a trigger. Suturesand devices of the invention are useful for securing a prosthetic deviceto a tissue or for wound closure or any other medical need requiring theuse of a suture.

FIGS. 1A and 1B depict a suture applicator 100 according to certainembodiments. Suture applicator 100 is adapted to place and secure atleast one suture inside a tissue during a minimal invasive surgicaloperation. Suture applicator 100 has an applicator section 101 and ahandle section 102 connected via shaft 103. Applicator section 101 isadapted to pass through an incision or standard trocar, and to makecontact with, and insert a suture into, the tissue.

Handle section 102 allows a practitioner to control suture application.Handle section 102 includes trigger 105, which may generally include alever mechanism. Operation of trigger 105 delivers and fastens a sutureas described below.

In certain embodiments, shaft 103 is articulated around an articulationjoint 104 in order to place a suture inside the tissue in a correctangle in respect to the tissue surface (FIG. 1B). Handle 102 includesarticulation knob 106 adapted to control the articulation.

FIGS. 2A and 2B illustrate a suture 200 according to certainembodiments. Suture 200 includes wire 201. A hook 202 is connected toone end of wire 201 and a loop 202 is connected to the other end. Suture200 can include monofilament, multifilament or metallic material, inaddition it can be made from a biodegradable material.

Suture 200 is characterized by at least two configurations: an openconfiguration (FIG. 2A), in which hook 202 and loop 203 are notconnected to each other therefore allowing the insertion of suture 200into tissue; and a closed configuration (FIG. 2B) in which hook 202 isinserted through loop 203 therefore forming a closed loop and securingsuture 200 to the tissue.

In certain embodiments, loop 203 has a diameter that can be decreasedsuch that loop 203 is tightened (e.g., once hook 202 is inserted throughloop 203), thus preventing unintended disengagement of hook 202 fromloop 203. Tightening is accomplished by loop holder 204. Loop holder 204includes two holes 205 and 206. Wire 201 extends through hole 205 andhole 206. The wire 201 is connected to said loop holder 204 at hole 206(by welding gluing or any other attachment mean) while free movement ofwire 201 in relation the loop holder 204 at hole 205 is allowed. Thus,once tension is applied to wire 201, loop 203 is tightened.

Additionally or alternatively, hook 202 can be expanded once it isinserted through loop 203 (e.g., while loop 203 remains static).Expansion can be provided by shaping hook 202 as an arrowhead whichdeforms and compresses to pass through loop 203 and then expands back toits original shape.

FIGS. 3A-3G illustrate a method of delivering and fastening suture 200into tissue 300 (not shown). At the first stage (FIG. 3A), distal tip301 of suture applicator 100 is brought to the tissue surface. Next,suture 200 is inserted into the tissue by hook insertion needle 302 andloop insertion needle 303 (FIG. 3B).

Hook insertion needle 302 is adapted to insert hook 202 of suture 200into tissue 300. In some embodiments, hook insertion needle 302 ischaracterized by an open cross section (e.g. “C” shaped) such that hookinsertion needle 302 could be removed from suture 200 once the suture isclosed. Hook insertion needle 302 is characterized by a sharp distal tip304 adapted to penetrate through tissue 300. Distal tip 304 of hookinsertion needle 302 includes two of lateral groove 305 to hold hook 202during said insertion.

Loop insertion needle 303 is adapted to insert loop 203 into tissue 300in curved path such that loop 203 is positioned directly above hook 202.Loop insertion needle 303 has a flexible needle 306 housed inside aninsertion tube 307. Flexible needle 306 is characterized by a sharp andnarrow tip adapted to penetrate the tissue while holding loop 203. Thedistal section of flexible needle 306 is pre-curved (see FIG. 3C).During initial insertion, flexible needle 306 is held straight insidesaid insertion tube 307. In certain embodiments, flexible needle 306includes a super-elastic material such as, for example, Nitinol.

As shown in FIG. 3C, flexible needle 306 is extended out of saidinsertion tube 307, penetrating tissue 300 in a curved path whilepulling and positioning loop 203 above hook 202 and distal tip 304 ofhook insertion needle 302. Flexible needle 306 can then be retractedback into said insertion tube 307 (FIG. 3D), leaving loop 203 inside thetissue above hook 202.

At the next stage (FIG. 3E), hook insertion needle 302 is advancedfurther into the tissue while inserting hook 202 through loop 203. Inthis stage, tension is applied at suture 200, which causes loop 202 thetighten around said needle 302.

At the next stage (FIG. 3F), hook insertion needle 302 is retracted,leaving hook 202 located inside said loop 203.

At the final stage (FIG. 3G), both of hook insertion needle 302 and loopinsertion needle 303 are removed from the tissue. Additional tension canbe applied the suture 200, causing further tightening of loop 203 andleaving suture 200 secured inside the tissue.

In certain embodiments, a reticulation of the distal end of sutureapplicator 100 allows the distal tip to be rotated around itslongitudinal axis. This can allow the application of sutures in variousorientation in respect to said suture applicator 100.

Reference is now made to FIGS. 4A-4D, which illustrates use of sutureapplicator 100 for securing a hernia mesh 400 to the abdominal wall 401during laparoscopic hernia repair surgery. In certain aspects, theinvention provides devices and methods for securing mesh 400 to tissue.Methods include inserting a distal portion of suture applicator 100 intoa patient's abdominal cavity through a trocar 402 or through an incision(FIG. 4A). Applicator section 101 can be articulated via articulationknob 106 (FIG. 4B). Distal tip 301 is pressed against hernia mesh 400(FIG. 4C) and a single suture is delivered through the tissue and herniamesh 400 and secured in place by pressing lever 107 on handle 102. Tip301 is then removed as shown in FIG. 4D.

Reference is now made to FIGS. 5A-5B which show use of suture applicator100 for closure of wound 500. According to this embodiment, sutureapplicator 100 comprises a body 501 and activation lever 502 adapted toinitiate suture application by the user. According to this embodiment, awound is closed by pressing the distal tip 503 of suture applicator 100to wound 500 (FIG. 5A) and applying at least one suture 200 through bothsides of said wound 500 (FIG. 5B).

FIGS. 6A-6H illustrate a mechanism of action for wound closure. Theprocess is similar to the one shown in FIGS. 3A-3G, however it includesa step for bringing two sides of a wound together before securing suture200 to the tissue. For illustration purposes, the tissue and the woundis not shown in these drawings.

At the first stage (FIG. 6A), distal tip 503 of suture applicator 100 ispressed against the tissue with wound 500 located roughly at the centerof said distal tip 503. Next, hook insertion needle 302 and loopinsertion needle 303 are inserted to the tissue together with suture 200(FIG. 6B) Then, the two needles 302 and 303 are brought together,bringing the sides of the wound together (FIG. 6C). Then, as shown inFIGS. 6D-6H, the suture is applied and secured in a similar way asdescribed above in reference to FIGS. 3C-3G, resulting in suture 200passing thorough both sides of wound 500, thus closing the wound.

In certain embodiments, suture applicator 100 can hold at least one andpreferably two or more of suture 200. Once one suture is applied to thetissue, another suture 200 is loaded on hook insertion needle 302 andloop insertion needle 303 in preparation to the next suture application.

Suture applicator 100 can be disposable or reusable. In the first case,suture applicator 100 is delivered together with one or more of suture200 and disposed of after use. If suture applicator 100 is reusable, itis adapted for re-sterilization and sutures can be provided separatelyin a cartridge than can be loaded before or during the operation. Thecartridge can provide parts of the suture application mechanism (e.g.applicator section 101, insertion needles 302, 303).

A suture 200 can pass through the entire thickness of the tissue or canbe embedded inside the tissue. Further, suture 200 can be appliedmanually, without the use of suture applicator 100. To apply suture 200manually, a suturing needle is attached to either of or both of the endsof suture 200 and used to insert suture 200 into tissue.

While described above in reference to FIGS. 2A and 2B as having agenerally wire-like structure in which loop 203 can be made smaller by acinching action through loop holder 204, a suture according to theinvention can have other structures and forms.

FIGS. 7A-7C show a suture 250 according to certain embodiments. Incertain embodiments, the suture is integrally formed. Suture 250generally includes a body member 251 having a first member 253 at oneend and a second member 252 at the other. As shown in FIGS. 7A-C, firstmember 253 includes a hook and second member 252 includes a loop.

Suture 250 further includes needle interface hook 261 at the loop end,and a hook-side needle interface hook 271 at the hook end. The loop endis characterized by aperture 265, that narrows towards the end of suture250, i.e., the aperture has a wide section and a narrow section, thenarrow section being distal to the wide section. Loop end further hasinsertion slope 277 and hook-side insertion slope 273, which can be, forexample, beveled tips, to aid insertion of suture 250 through tissue.

Suture 250 generally includes at least one barb 269 at the hook end.When the hook end is inserted through aperture 265, as shown in FIG. 7B,one or more of barb 269 (two are shown) tend to prevent retraction ofthe hook end out of and away from the loop end. As shown in FIGS. 7A-7C,each of barbs 269 has a fin-like structure and is adapted to be bentduring insertion. Further, in certain embodiments, aperture 265 of firstmember 253 is dimensioned to be not substantially larger than secondmember 252. For example, the width defined by one or more of barb 269can be greater than the width defined by aperture 265 at its widestpoint. Insertion of second member 252 through aperture 265 generallyinvolves either of second member 252 or first member 253 deformingslightly for insertion. The fin-like structure of barb 269 can bendtowards body 251, first member 253 can stretch, first member 253 andsecond member 252 can twist relative to one another, or a combinationthereof. Deformation can be elastic (return to original conformation) orplastic or a combination thereof.

As shown in FIG. 7B, tension on suture 250 will tend to slide secondmember 252 towards the narrow portion of aperture 265. This results inthe locked conformation illustrated in FIG. 7C, in which the stem partof second member 252 (e.g., a portion substantially similar in crosssection to that of body member 251) is slid into and occupies thenarrowest part of aperture 265. This serves to lock suture 250 into aclosed conformation.

As shown in FIG. 7A, second member 252 can include needle interface hook271 while the loop-end includes loop interface hook 261. Needleinterface hook 271 and loop interface hook 261 are illustrated asprotrusions that generally taper to be smaller extending towards an endof suture 250. As shown in FIG. 7A, these interface hooks include a backportion that presents a push-able surface towards the main body portionof suture 250. In certain embodiments, one or both of these push-ablesurfaces are presented by indentations into suture 250 or otherstructures. The function of needle interface hook 271 and loop interfacehook 261 are illustrated in FIGS. 8A and 8B.

As shown in FIGS. 8A and 8B, the delivery tip of applicator section 101of suture applicator 100 provides a mechanism for delivering suture 250to tissue and fastening it there. Hook insertion needle 352 is slidablydisposed within applicator section 101 and configured to interface withsecond member 252 via needle interface hook 271. Loop insertion needle357 extends from insertion tube 356 and similarly interacts with firstmember 253 via loop interface hook 261. As shown in FIG. 8A, applicatorsection 101 optionally includes a spacer 807 to assist in precisepositioning of suture 250.

FIG. 8B in combination with FIG. 8A illustrates the coordinatedfunctioning of the insertion needles of applicator section 101. As shownin FIGS. 8A and 8B, hook insertion needle 352 has and maintains asubstantially straight conformation as it assists in driving a hook endof suture 250 into tissue. Loop insertion needle 357 has a shape memorymaterial such that, when the needle is contained within applicatorsection 101, the needle exhibits a shape substantially similar to, orgoverned by, a shape of applicator section 101. When loop insertionneedle 357 is extended out from applicator section 101, loop insertionneedle exhibits a curved shape (FIG. 8B).

Applicator section 101 is configured to deliver suture 250 by pushingeach of its ends into tissue. Delivery is coordinated by the independenttranslation of push rods (not shown in FIGS. 8A and 8B) operably coupledto hook insertion needle 252 and loop insertion needle 357. Coordinationof delivery involves extending hook end of suture 250 away fromapplicator section 101 while also extending loop end of suture 250 andbringing the two ends of the suture together (e.g., through theoperation of a shape memory material in loop insertion needle 357).

In certain embodiments, a leading edge of either or both of theinsertion needles is at least partially sharpened to aid in penetrationof tissue. Each of needle interface hook 271 and loop interface hook 261can have a back surface that gets pushed by the corresponding insertionneedle. Alternatively or additionally, either needle interface hook caninclude a slot and a portion of the corresponding insertion needle canbe dimensioned to engage the slot. By these means, the needles can drivesuture 250 into tissue and when the insertion needles are retracted,they disengage with suture 250 leaving it in place and fastened in aclosed loop.

With reference to FIG. 1B, applicator section 101 and shaft 103 caninclude articulation joint 104. FIGS. 9A and 9B show a structure bywhich articulation joint 104 can allow shaft 103 to bend while stilloperating according to the embodiment described herein. As shown in FIG.9A, articulation joint 104 includes a plurality of living hinge 913. Aliving hinge 903 generally includes a flexible portion and a flange 901.One or more of push rod 909 extend through joint 104 generally disposedso that, where there are multiple push rods, an axis of each push rodexhibits the same radius as the others when hinge 104 is bent. Flange901 can be provided to limit the radius of curvature of hinge 104 tooptimize functionality of applicator section 101, for example, bypreventing the push rods from being bent too much.

Hinge 104 further includes an articulation cable 905 with anarticulation wire ending 917 disposed on a distal side of hinge 104 fromhandle 102 (not pictured). When articulation wire 917 is pulled by amechanism in handle 102 (discussed in more detail below), articulationwire ending 917 exhibits a compressive force on hinge 104, causing it tocompress on one side, while expanding on the other, thus forming a bendin shaft 103, as shown in FIG. 9B.

Articulation joint 104 can be made with any suitable material known inthe art such as, for example, an elastically deformable material. Incertain embodiments, the material is a low friction material such asPTFE to minimize friction between joint 104 and push rod 909.

Suture applicator is designed and dimensioned for use in laparoscopic orendoscopic surgery. Shaft 103 is dimensioned for use with endoscopictubes and apparatuses. The device can also be inserted through anincision or trocar and used within a body.

In certain embodiments, suture applicator 100 can hold at least one ofsuture 250 in a cartridge 801 that can be interchangeably loaded intoapplicator section 101 of suture applicator 100.

FIG. 10 shows a cartridge 801 having an insertion end 803 and a spacer807 oriented for insertion into applicator section 101. At the end ofapplicator section 101, FIG. 10 shows receiving pad 809 with loopinsertion needle 357 visible disposed therein. As can be seen depictedin the distal end of cartridge 101, second member 252 (specifically, aportion of needle interface hook 271) is held in a slot, oriented tointerface with hook insertion needle 352 in applicator section 101 (notvisible in FIG. 10). Receiving pad 809 can include an interior shapedimensioned to receive insertion end 803.

Cartridge 801 has a structure that cooperates with the mechanicalstructure of suture applicator 100 so that the device can deliver andfasten sutures within a body of a patient. Cartridge 801 accommodatessutures of different sizes.

In some embodiments, cartridge 801 uses an interchangeable spacer andspacers of different sizes accommodate different sutures. In certainembodiments, each cartridge holds a number of sutures of the same size.Spacers are provided to control the distance between the tip of thedevice and the tissue (or prosthesis) surface. For example, for smallersutures, a larger spacer is provided to prevent the suture frompenetrating too deeply into the tissue. Similarly, for larger sutures, asmaller spacer allows for good penetration depth of the suture.

FIG. 11 shows a thin spacer 806 for use with larger sutures. In someembodiments, the spacers are not interchangeable but instead formed aspart of a disposable cartridge 801. FIG. 12 shows a spacer 807 for usewith intermediate sutures. FIG. 13 shows a long spacer 808 for use withsmall sutures. As shown in FIGS. 10-13, a spacer may include a suturerelease slot disposed at an end of the body of the cartridge. In certainembodiments, cartridge 801 can be inserted into an end of an shaft 103via insertion end.

As can be seen in FIG. 10, when cartridge 801 is inserted into shaft103, second member 252 makes contact with hook insertion needle 352 vianeedle interface hook 271 and first member 253 makes contact with loopinsertion needle 357. Suture 250 is delivered to tissue by the action ofpush rods that drive the insertion needles. Each push rod, and thus eachneedle, translates parallel to an axis of shaft 103 relative to eachother as well as to member 103. In a preferred embodiment, said suturesare stacked one on top of the other inside cartridge 801; during eachsuture application cycle, a single suture is connected to the saidinsertion needles and then inserted into the tissue. At the end of theapplication cycle, a suture is advanced to the top of the cartridge inpreparation to the next application cycle. In another embodimentcartridge 801 includes an indicator which visually indicates to thesurgeon when the cartridge is almost empty (e.g. 1 or 2 sutures remainsin the cartridge) and or completely empty. Motion of the push rods isgoverned by the mechanical structure of applicator 100.

FIG. 14 gives a view of components of a handle of a suturing device. Ascan be seen in FIG. 14, one or more of push rod 135 are linked to one ormore of translator bar 131. Translator bar 131 has a pin 127 fixed intoa slot 123 of slot wheel 115. As shown in FIG. 14, applicator 100includes a second slot wheel 119. Additional slot wheels (not shown) maybe included. The rotation of the slot wheel is driven through gearmechanism 111 by a geared face 107 of trigger 105.

By the relationship of these parts, when trigger 105 is squeezed, eachof the slot wheels rotate. Because each slot (e.g., slot 123) isirregularly shaped (e.g., not a circle concentric with slot wheel 115),the corresponding translator bar translates independently relative tohandle 102 and with acceleration defined by the disposition of the slot.The independent translation of translator bar 131 causes the independenttranslation of push rod 135 which (looking back at FIGS. 8A and 8B)cause the independent action of hook insertion needle 352 and loopinsertion needle 357, as described above.

In certain embodiments, the series of coordinated motions of theinsertion needles, and the delivery of a suture, is operated andcoordinated electronically. For example, applicator device 100 caninclude servomotors operably connected to a governing circuit and/orchip. A motor can drive the slot wheels. Or, motors can drive each pushrod as governed by a chip executing instructions provided, for example,by a tangible, non-transitory computer memory such as, for example, afield-programmable gate array or a disc drive.

Where shaft 103 includes articulation joint 104, articulation knob 106controls the flexure of joint 104. Knob 106 is rotated by a user (e.g.,with a thumb). During the rotation, articulation cable 905 (shown inFIGS. 9A and 9B) is wrapped around the knob's axis, pulling it towardthe handle, articulating joint 104. Knob 106 can include one or more ofsocket 139 adapted to fit a ball plunger in place once a desired degreeof articulation is obtained.

The invention further provides methods for closing a wound that involvedeploying suturing device 100 to deliver a suture to a wound. Woundclosure according to methods of the invention involves positioning thedelivery tip close to the wound. Where the wound is inside the body, theshaft 103 is inserted through an incision, trocar, or endoscopicchannel. A suture is delivered and formed into a closed configuration bydevice 100.

When a practitioner depresses trigger 105, loop insertion needle 357extends from insertion tube 356 and interacts with first member 253 vialoop interface hook 261. Hook insertion needle 352 has and maintains asubstantially straight conformation as it assists in driving a hook endof suture 250 into tissue. When loop insertion needle 357 is extendedout from applicator section 101, it curves to guide the fastening of thesuture.

Suture 250 is delivered by pushing each of its ends into tissue.Delivery is coordinated by the independent translation of push rodsoperably coupled to hook insertion needle 252 and loop insertion needle357, which is triggered through the use of trigger 105. Coordination ofdelivery involves extending hook end of suture 250 away from applicatorsection 101 while also extending loop end of suture 250 and bringing thetwo ends of the suture together (e.g., through the operation of a shapememory material in loop insertion needle 357). Methods include using theneedles to drive suture 250 into tissue and retracting the needles sothey disengage from suture 250 leaving it in place and fastened in aclosed loop, closing the wound.

The invention also provides methods for securing a medical prosthesis totissue. Securing the prosthesis is accomplished through delivering asuture to a target tissue that has a prosthesis applied to it, usingapplicator 100. Methods include inserting a distal portion of sutureapplicator 100 into a patient's abdominal cavity through a trocar orthrough an incision. The distal end is pressed against the hernia meshand a suture is delivered through the tissue and hernia mesh and securedin place by pressing trigger 105 on handle 102. Shaft 103 is thenremoved.

Delivery according to the methods of the invention causes the first endof the body to mate with and be retained by the second end of the body,thereby forming the suture into a closed configuration and securing theprosthesis to the tissue. The prosthesis can be secured by employing afastening structure provided by the first and second members.

During delivery, hook insertion needle 352 interfaces with second member252 via needle interface hook 271. Loop insertion needle 357 extendsfrom insertion tube 356 and similarly interacts with first member 253via loop interface hook 261.

Loop insertion needle 357 is extended out from applicator section 101and curves to guide the suture through the prosthesis. Delivery iscoordinated by the independent translation of push rods (discussedabove) operably coupled to hook insertion needle 252 and loop insertionneedle 357. Coordination of delivery involves extending hook end ofsuture 250 away from applicator section 101 while also extending loopend of suture 250 and bringing the two ends of the suture together(e.g., through the operation of a shape memory material in loopinsertion needle 357). Methods can include pushing a suture through aback surface of needle interface hook 271 and loop interface hook 261with a corresponding insertion needle. By these means, the needles candrive suture 250 into the prosthesis (e.g., hernia mesh). The needlesare then retracted, leaving suture 250 in place and fastened in a closedloop securing the prosthesis to the tissue.

FIGS. 15A-15C depict a suture 250 according to certain embodiments. FIG.15A shows suture 150 in an open configuration, while FIG. 15B showssuture 250 in a closed configuration. FIG. 15C shows suture 250 in alocked configuration. Suture 250 includes insertion slope 277 and atleast one barb 269 that are dimensioned to operate with hook insertionneedle 352 and loop insertion needle 357 of the embodiment shown inFIGS. 16 and 17. First member 253 includes a hook and second member 252includes a loop

FIG. 16 shows a suture applicator with suture 250 according to certainembodiments. FIG. 17 shows the suture applicator of FIG. 16, without asuture 250. FIG. 16 shows loop insertion needle 357 and hook insertionneedle 352. As shown in FIG. 16, the needle integration section 935 isshaped as a continuation of the needle tip in order to a allowpenetration through the mesh and the tissue layers. Specifically, suture250 includes insertion slope 277 and the applicator includes a slopedneedle integration section 935 that are dimensioned to cooperate toprovide a substantially smooth, continual slope. Bulges 931 prevent themesh fibers and the tissue from being caught between suture 250 and hookinsertion needle 352. As shown in FIG. 17, slot 937 is operable to holdthe hook side of suture 250 in place during penetration, e.g., byengaging barbs 269.

FIGS. 18A-18F depict the operation of applicator section 101 of thesuture applicator depicted in FIGS. 16 and 17. FIG. 16A shows an initialstage of operation. Hook insertion needle 352 and loop insertion needle357 are fully engaged with first member 253 and second member 252,respectively, of suture 250. As seen in FIG. 18B, the loop is fullydeployed and the hook partially penetrates the loop. In FIG. 18C, hookinsertion needle 352 holds the loop in place while the loop insertionneedle 357 is retracted.

FIGS. 18D-18F show locking and release of suture 250. FIG. 18D showshook insertion needle 352 pushing the hook through the loop. As shown inFIG. 18E, since the hook is slightly wider than the loop's wide section,first member 253 is caught in second member 252 and removed from thehook insertion needle 352 once hook insertion needle 352 is retracted.FIG. 18F shows that, once tension is applied on the clip, the hookslides to the narrow section of the hook. In this stage the clip islocked.

FIG. 19 shows the structure of the clip feeder 919. FIG. 17 shows hookinsertion needle 352 lies under front feeder cover 941, which includesmarker slot 943. Front cover 941 covers hold comb 945. Clip stack 955includes a plurality of suture 250 extending from clip support slide953, which also includes marker pin 947. Front cover 941 and back cover959 covering and holding the clip stack 955 and the clip support 953,said front and back cover are encapsulated within the shaft cover 949and terminate at shaft cap 939. Comb driver assembly 951 with combdriver hook 948 operates drive comb 957, as described below. Clip feeder919 includes loop insertion needle 357 disposed near clip spreader 961.Shaft cap 939 includes a loop collection slot 963 and a hook collectionslot 964. Clip feeder 919 functions to deliver one suture 250 from clipstack 955 per operation of device 100.

FIG. 20 illustrates an assembled clip feeder 919. In operation, the combdriver assembly 951 first generates a single up and down stroke of theback drive comb at the end of each application cycle. As a response tothe stroke, the entire clip stack 955 is pushed forward by the drivecomb 957. During this process the hold comb 945 (not shown) prevents adownward movement of the sutures 250 in clip stack 955. Once the clipsstack 955 is pushed upward (e.g., forward), the last suture 250 isspread by the clip spreader 961 and is positioned at the collectionslots 963 and 964, ready to be collected by the insertion needles 352and 357 during the next application cycle. Each suture 250 supports thenext suture 250 and prevents the lateral movement of its middle while itis pushed by drive comb 957. The last suture 250 is supported by theclip support slide 953. Clip support slide 953 is pushed by the drivecomb 957 together with the clips. A marker pin 947 may protrudes to theouter surface of the shaft, through the marker slots at the feedercovers 941, to indicate to the surgeon how many clips remains in thedevice.

FIG. 21 shows the positioning of a suture 250 in clip feeder 919. Thearms of spreader 961 are flexible and can flex toward the center of theshaft in order to allow the ends of suture 250 to exit from the device.Spreader 961 also provides resistance in order to allow the integrationbetween needle and the suture 250 and hold the last suture 250 in placebefore its application. The last suture 250 is pushed forward againstthe spreader 961 by the drive comb 957. As a result, the ends of suture250 are spread into the collection slots 963 and 964 from which they arecollected by the insertion needles during the insertion process. Thebottom side of the spreader 961 in sloped in order to allow theextraction of suture 250 once it was collected by the insertion needles.

FIGS. 22A-22E show the advancement of a suture 250 through clip feeder919. FIGS. 22A-22E are cross-sections of a distal end of clip feeder 919and they depict a loading of a new suture 250 into the collection slots963 and 964 once a clip suture 250 is applied. FIG. 22A shows shaftcover 939 with clip spreader 961 therein. Also visible is suture 250,being controlled by drive comb 957 and hold comb 945. In an initialstage in FIG. 22A, after the first suture 250 is collected and insertedinto the tissue, the next suture 250 is placed below the collectionslots 963 and 964. As shown in FIG. 22B, drive comb 957 is moving backwhile the hold comb 945 is holding the clips stack 955 in place. Theteeth of the drive comb 957 are bent while they are climbing over theclip stack 955. FIG. 22C shows drive comb 957 engaged with bottomsection of the sutures in clip stack 955.

FIG. 22D shows drive comb 957 pushing one of sutures 250 forward andtoward the spreader 961 while climbing over the teeth of the hold comb945 (which are bent during the process). As seen in FIG. 22E, the nextsuture 250 is positioned at the collection slots 963 and 964 and isready to be collected by the insertion needles 352 and 357.

FIGS. 23A-23E depict the operation of the comb driver mechanism of clipfeeder 919. As seen in FIG. 23A, comb driver assembly 951 provides aconnection between comb driver hook 948 plus comb driver slide 975 anddrive comb 957. Release slope 977 and release bulge 976 cooperate torelease the comb driver hook from the hook insertion needle. Comb driverspring 981 can be seen by hook slot 983. The comb driver hook 948 isconnected to the comb driver slide 975 by a flexible pin, allowing itsrotation. FIG. 21A shows an initial stage, in which hook insertingneedle 352 is positioned backward. Hook engagement is depicted in FIG.21B. Once an application cycle starts, hook insertion needle 352 ismoved forward. Once the hook slot 983 is positioned in front of the combdriver hook 948, the comb driver hook 948 springs into hook slot 983.

FIG. 23C depicts a pulling back stage. At the final stage of theapplication cycle, the hook insertion needle 352 moves back whilepulling the back the comb driver slide 975 and the drive comb 957 whilepressing the comb driver spring 981. During this movement the comb teethare engaged with sutures 250. FIG. 23D shows release. Once the releasebulge 976 reaches the release slope 977, release bulge 976 is pushedlaterally and removes the hook 948 out of the hook slot 983. FIG. 23Eshows advancement of suture 250. The compressed spring 981 pushes thecomb driver 951 and the drive comb 957 forward while advancing theentire clip stack 955.

FIG. 24 depicts a cartridge 801 that can be the entire distal section101 of the device 100 and hold the feeder mechanism according to certainembodiments of the invention. Any suitable mechanism for loading suturesmay be used. For example, as discussed above, sutures can be provided ina cartridge 801 that is loaded into the shaft 103. FIG. 24 depicts analternative mechanism in which the cartridge 801 is inserted over a hubportion along shaft 103. As shown in FIG. 24, a cartridge can beprovided that is configured to be connected to the handle section 102 bya hub section. The hub section can hold the cartridge 801 connected tothe handle 102 and deliver the movement from the handle mechanism to thepush rods. The locking and releasing of the cartridge to the hub can beobtained by rotating the cartridge inside the hub.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

1-26. (canceled)
 27. A suturing device comprising: a trigger on ahandle; an elongated shaft extending from the handle; at least oneself-locking suture disposed at least partially within the shaft; afirst needle member disposed at a distal end of a first push rodextending along the shaft; and a second needle member comprising aflexible, pre-shaped portion and disposed at a distal end of a secondpush rod extending along the shaft, wherein when the trigger is squeezedthe first needle member extends from the shaft along a straight pathparallel to a longitudinal axis of the shaft to deliver a first end ofthe suture through a tissue, and the second needle member extends fromthe shaft along a curved path to deliver a second end of the suturethrough the tissue and connect the second end to the first end, therebyfastening the suture beneath a surface of the tissue.
 28. The suturingdevice of claim 27, wherein one of the first end and the second endcomprises a hook and the other comprises a loop.
 29. The suturing deviceof claim 28, wherein a portion of the first push rod and a portion ofthe second push rod extend within the shaft and are parallel to thelongitudinal axis.
 30. The suturing device of claim 29, wherein theshaft is substantially cylindrical.
 31. The device of claim 30, whereinthe shaft is dimensioned for insertion through a trocar.
 32. The deviceof claim 31, wherein the shaft comprises an articulation joint.
 33. Thedevice of claim 32, wherein the articulation joint comprises at leastone living hinge to limit a radius of curvature of the joint.
 34. Thedevice of claim 29, wherein when the trigger is squeezed the firstneedle member and the second needle member engage the first end and thesecond end within the shaft and release the first end and the second endbeneath the surface of the tissue.
 35. The device of claim 34, whereinthe device is configured to insert the suture to a depth greater than adiameter of the shaft.
 36. The device of claim 35, wherein the device isadapted to insert the suture through a prosthetic mesh.
 37. The deviceof claim 29, wherein the device comprises a plurality of suturesdisposed at least partially within the shaft.
 38. The device of claim37, further comprising a clip feeder.
 39. The device of claim 38,further comprising a cartridge loaded with the at least one self-lockingsuture and disposed at least partially within the shaft.
 40. The deviceof claim 39, wherein the cartridge comprises a distal portion of theshaft.
 41. The device of claim 40, wherein the device is configured toreceive a cartridge from a set of cartridges, at least two carryingsutures of different sizes.
 42. The device of claim 41, wherein thedevice is configured to deliver sutures of different sizes to differentpenetration depths.
 43. The device of claim 37, further comprising anindicator that shows a number of sutures disposed at least partiallywithin the shaft.
 44. The device of claim 43, wherein the indicator isvisible on the shaft.
 45. A method of fastening a suture to a tissue,the method comprising: providing a device comprising: a trigger on ahandle; an elongated shaft extending from the handle; at least oneself-locking suture disposed at least partially within the shaft; afirst needle member disposed at a distal end of a first push rodextending along the shaft; and a second needle member comprising aflexible, pre-shaped portion and disposed at a distal end of a secondpush rod extending along the shaft, wherein when the trigger is squeezedthe first needle member extends from the shaft along a straight pathparallel to a longitudinal axis of the shaft to deliver a first end ofthe suture through a tissue, and the second needle member extends fromthe shaft along a curved path to deliver a second end of the suturethrough the tissue and connect the second end to the first end, therebyfastening the suture beneath a surface of the tissue; contacting adistal tip of the shaft with the tissue; and squeezing the trigger,thereby fastening the suture to the tissue.
 46. The method of claim 45,further comprising inserting a distal portion of the shaft through atrocar.